87 FR 199 pgs. 62866-62867 - Prospective Grant of Exclusive Patent License: Radiotherapeutics for Nasopharyngeal Cancer
Type: NOTICEVolume: 87Number: 199Pages: 62866 - 62867
Pages: 62866, 62867FR document: [FR Doc. 2022-22476 Filed 10-14-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: National Institutes of Health
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Radiotherapeutics for Nasopharyngeal Cancer
AGENCY:
National Institutes of Health, HHS.
ACTION:
Notice.
SUMMARY:
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Molecular Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its principle place of business in West Chester, Pennsylvania, to practice the inventions embodied in the issued patents and patent applications listed in the Supplementary Information section of this notice.
DATES:
Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development November 1, 2022 will be considered.
ADDRESSES:
Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent license should be directed to: Michael Davis, JD, Ph.D., Deputy Director, NHLBI OTTAD, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301-451-9032, or michael.davis4@nih.gov.
SUPPLEMENTARY INFORMATION:
The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement to MTTI:
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| NIH Ref No. | Patent No. or patent application No. | Issue date | Filing date | Title |
|---|---|---|---|---|
| E-150-2016-0-US-01 | 62/333,427 | May 9, 2019 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. | |
| E-150-2016-0-PCT-02 | PCT/US2017/031696 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. | |
| E-150-2016-0-CN-03 | 201780029003X | November 9, 2018 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. | |
| E-150-2016-0-EP-04 | 3455206 | November 4, 2020 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-JP-05 | 2018-558662 | TBD (Allowed) | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-US-06 | 10,696,637 | June 30, 2020 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-SG-07 | 11201809982R | November 8, 2021 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-CH-08 | 3455206 | November 4, 2020 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-DE-09 | 3455206 (Certificate No. 602017027023.7) | November 4, 2020 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-FR-10 | 3455206 | November 4, 2020 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-GB-11 | 3455206 | November 4, 2020 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-IE-12 | 3455206 | November 4, 2020 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-0-IT-13 | 3455206 | November 4, 2020 | May 9, 2017 | Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. |
| E-150-2016-1-PCT-01 | PCT/US2017/054863 | October 3, 2017 | Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. | |
| E-150-2016-1-CN-02 | 201780095506.7 | October 3, 2017 | Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. | |
| E-150-2016-1-EP-03 | 17928082.1 | October 3, 2017 | Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. | |
| E-150-2016-1-JP-04 | 2020-519137 | October 3, 2017 | Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. | |
| E-150-2016-1-SG-05 | 112020002882V | October 3, 2017 | Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. | |
| E-150-2016-1-US-06 | 10,981,866 | April 20, 2021 | October 3, 2017 | Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. |
| E-150-2016-1-HK-07 | 62020015610.2 | October 3, 2017 | Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. |
The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective patent license may be granted in a field of use directed to radiotherapeutics for nasopharyngeal cancer and the extent of the exclusive license may be territorially restricted to the United States, its Territories, Commonwealths and Possessions; and Asia.
The invention pertains to a radiotherapeutics against cancers that express somatostatin receptor. Radionuclide therapy directed against tumors that express somatostatin receptors (SSTRs) has proven effective for the treatment of advanced, low- to intermediate-grade neuroendocrine tumors. The subject radiotherapeutic covered by the patent estate includes a somatostatin (SST) peptide derivative like octreotate (TATE), conjugated to an Evans Blue (EB) analog, and further chelated via DOTA to therapeutic radionuclide 177 Lu, a beta emitter. The EB analog reversibly binds to circulating serum albumin and improves the pharmacokinetics of SST peptide derivatives and reduce peptide-receptor radionuclide therapy toxicity. EB analog conjugated to octreotate (EB-TATE) has been shown by the inventors to provide reversible albumin binding in vivo and extended half-life in circulation. When EB-TATE is slowly released into the tumor microenvironment, tumor uptake and internalization into SSTR positive tumors resulted in delivery of radioactive particles and tumor cell killing. EB-TATE displayed significantly more favorable pharmacokinetics than TATE alone by achieving higher tumor to non-tumor penetration as evidenced by positron emission tomography.
Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license.
Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Michael D. Davis,
Deputy Director, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development.
[FR Doc. 2022-22476 Filed 10-14-22; 8:45 am]
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